- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04377789
Effect of Quercetin on Prophylaxis and Treatment of COVID-19
February 17, 2021 updated by: Hasan Onal, Kanuni Sultan Suleyman Training and Research Hospital
The Possible Effect of Quercetin on Prophylaxis and Treatment of COVID-19
Novel Coronavirus is defined to be the cause of COVID-19, recently.
It's known that COVID-19 goes with excessive immune reaction of human body in severe cases.
The investigators hypothesize that quercetin, as a strong scavenger and anti-inflammatory agent, can be effective on both prophylaxis and treatment of COVID-19 cases.
Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Novel Coronavirus is defined to be the cause of COVID-19, recently.
It's known that COVID-19 goes with excessive immune reaction of human body in severe cases.
Quercetin is reported to be effective on treatment and prophylaxis of other SARS like coronavirus infections, as a strong antioxidant and scavenger flavonoid without any adverse events.
Upon this data, the investigators hypothesize that quercetin can be effective on both prophylaxis and treatment of COVID-19 cases.
Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.
Study Type
Interventional
Enrollment (Actual)
447
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34303
- Kanuni Sultan Suleyman Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- moderate-high risk for COVID-19
- obtained informed consent
Exclusion Criteria:
- declined to participate
- genetic/chromosomal abnormalities
- any kind of sensitivity or allergy for quercetin
- history of previous hypersensitivity with quercetin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: non-quercetin group
Participants, who accept to enroll the study without having quercetin prophylaxis and who do not have a history of COVID-19, will be in this group.
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Active Comparator: quercetin prophylaxis group
Participants, who takes a daily dose of 500mg quercetin and who not have a history of COVID-19, will be in this group.
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a daily dose of quercetin (500mg) will be taken by non-COVID-19 intervention group 1
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Active Comparator: quercetin treatment group
Participants, who takes a daily dose of 1000mg quercetin and who are proven cases for COVID-19, will be in this group.
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a daily dose of quercetin (1000mg) will be taken by proven COVID-19 cases intervention group 2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of COVID-19 calculated using a questionnaire
Time Frame: 3 months
|
Prevalence of COVID-19 in prophylaxis and sham group will be calculated using a questionnaire including hospital records
|
3 months
|
Standardized Mortality rate
Time Frame: 3 months
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Mortality rate will be compared between two groups
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morbidity rate
Time Frame: 3 months
|
Morbidity rates besides recovery rates from COVID-19 will be documented
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2020
Primary Completion (Actual)
July 31, 2020
Study Completion (Actual)
August 31, 2020
Study Registration Dates
First Submitted
May 1, 2020
First Submitted That Met QC Criteria
May 5, 2020
First Posted (Actual)
May 6, 2020
Study Record Updates
Last Update Posted (Actual)
February 18, 2021
Last Update Submitted That Met QC Criteria
February 17, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Antioxidants
- Quercetin
Other Study ID Numbers
- KSSEAH--0058
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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